Phase 3 Study of KHK7580
1 other identifier
interventional
39
1 country
1
Brief Summary
This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedStudy Start
First participant enrolled
September 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2016
CompletedJuly 5, 2017
July 1, 2017
1.2 years
September 9, 2015
July 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
Weeks 30-32
Secondary Outcomes (2)
Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
Weeks 30-32
Mean percent change in the evaluation period in intact PTH level from baseline
Weeks 30-32
Study Arms (1)
KHK7580
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Personally submitted written voluntary informed consent to participate in the study
- Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening
- Intact PTH level of \> 240 pg/ml at screening
You may not qualify if:
- Treatment with cinacalcet hydrochloride within 2 weeks before screening;
- Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
- Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
- Severe heart disease;
- Severe hepatic dysfunction;
- Uncontrolled hypertension and/or diabetes;
- Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
- Primary hyperparathyroidism;
- Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Tokyo, Japan
Related Publications (1)
Tsuruya K, Shimazaki R, Fukagawa M, Akizawa T; Evocalcet Study Group. Efficacy and safety of evocalcet in Japanese peritoneal dialysis patients. Clin Exp Nephrol. 2019 Jun;23(6):739-748. doi: 10.1007/s10157-019-01692-y. Epub 2019 Apr 6.
PMID: 30955188DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 15, 2015
Study Start
September 29, 2015
Primary Completion
December 22, 2016
Study Completion
December 22, 2016
Last Updated
July 5, 2017
Record last verified: 2017-07